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临床试验/NCT02988219
NCT02988219已完成4 期

Evaluation of Cardiac Arrhythmias in Patients Undergoing Kidney Cancer Surgery Depending on the Anaesthesia Method

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period

研究概览

简要总结

This study evaluates the incidence of cardiac arrhythmias during the perioperative period in patients undergoing open kidney cancer surgery in the lateral position. All the participants will be randomly allocated to receive general (Group G) or combined epidural/general anaesthesia (Group G/E). The anaesthetic technique is standardized. The Holter monitor will be applied at the evening before the surgery, tracing continuously for a period of 24 hours (7PM-7PM)

详细描述

Cardiac arrhythmias are a common complication during and after cardio-thoracic surgery. They are also a major source of morbidity and mortality. After general surgery, they usually do not require clinically significant management but the literature on this topic is obsolete. There is no literature data about their incidence during kidney surgery in the lateral position when the bed is scissored so the legs and head are low. The aim of this study was to define what types of arrhythmias are the most common during kidney cancer surgery, their incidence and whether combining general with epidural anesthesia prevents them.

An approval from the Medical University of Warsaw Bioethical Committee has been obtained. Patients need to give written informed consent to participate in the study.

It is anticipated that 50 patients with open kidney cancer surgery performed in the lateral position, under general or combined anesthesia will be enrolled.

A Holter ECG monitor (3-chanel, leads CM5) will be applied at the evening before the surgery, tracing continuously for a period of 24 hours (7PM-7PM).

Patients will be randomly allocated (random permuted blocks within strata) to receive general or combined epidural/general anesthesia. The anesthetic technique is standardized. All the data registered by the Holter ECG monitor will be analyzed and compared with the nursery and anesthesia records.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Open renal cell carcinoma surgery, lateral position
  • American Society of Anesthesiologists (ASA) physical grade I-III
  • No history of cardiac arrhythmias
  • Informed consent

排除标准

  • Pregnancy and breast feeding
  • Contraindications for epidural anesthesia
  • Laparoscopic or robotic surgery
  • Suspected difficult intubation (ex. fibroscopic)
  • Chest deformations
  • Prior cardiac/thoracic surgery
  • Cardiac insufficiency
  • abnormal ECG before the surgery

研究组 & 干预措施

General anesthesia (G)

Active Comparator

Holter ECG monitor General anesthesia Open kidney cancer surgery

干预措施: Holter ECG monitor (Device)

General anesthesia (G)

Active Comparator

Holter ECG monitor General anesthesia Open kidney cancer surgery

干预措施: Open kidney cancer surgery (Procedure)

General anesthesia (G)

Active Comparator

Holter ECG monitor General anesthesia Open kidney cancer surgery

干预措施: General anesthesia (Procedure)

Combined general/epidural (G/E)

Experimental

Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery

干预措施: Bupivacaine-fentanyl (Drug)

Combined general/epidural (G/E)

Experimental

Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery

干预措施: Holter ECG monitor (Device)

Combined general/epidural (G/E)

Experimental

Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery

干预措施: Open kidney cancer surgery (Procedure)

Combined general/epidural (G/E)

Experimental

Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery

干预措施: General anesthesia (Procedure)

Combined general/epidural (G/E)

Experimental

Holter ECG monitor Epidural anesthesia General anesthesia Open kidney cancer surgery

干预措施: Epidural Anaesthesia (Procedure)

结局指标

主要结局

Incidence of Perioperative Cardiac Arrhythmias Evaluated by a Continuous ECG Holter Monitoring in the Perioperative Period

时间窗: 60 months

The investigator evaluates the incidence of cardiac arrhythmias, the type of arrhythmias and whether additional interventions were needed to treat them Arrhythmias observed: tachycardia \>100 bpm bradycardia \< 50 bpm pause (P-P interval \> 2 seconds) ventricular extrasystoles (VE) \> 1000/ 24 hours supraventricular extrasystoles (SVE) \>200/24 hours

次要结局

  • The Prevention of Cardiac Arrhythmias Occurence by Epidural Anesthesia Added to General Anesthesia Evaluated by a Number and Type of Arrhythmias Observed(60 months)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Principal Investigator
主要研究者

Karolina Dobrońska

M.D.

Medical University of Warsaw

研究点 (1)

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